Suturing device for minimally invasive surgery and needles and methods thereof

ABSTRACT

A suturing device for minimally invasive surgery is disclosed. The suturing device has a head defining one or more ferrule holders and a tissue bite area. The device also has a first needle comprising a flywheel portion and one or more curved arms extending from the flywheel portion, each of the one or more curved arms comprising a ferrule engaging tip, wherein the first needle is pivotably coupled to the head. The suturing device further has a first actuator coupled to the first needle and configured to rotate it from a retracted position, where the ferrule engaging tip of each of the one or more curved arms starts away from the one or more ferrule holders, through the tissue bite area, and to an engaged position where the ferrule engaging tip of each of the one or more curved arms is operationally aligned with the one or more ferrule holders.

CROSS REFERENCE TO RELATED APPLICATIONS

This disclosure claims the benefit of priority as a continuation under35 U.S.C § 120 to U.S. application Ser. No. 14/727,235 filed Jun. 1,2015 and entitled “Suturing Device for Minimally Invasive Surgery andNeedles and Methods Thereof,” the contents of which is herebyincorporated by reference in its entirety for all purposes.

FIELD

The claimed invention relates to surgical suturing, and morespecifically to minimally invasive surgical suturing devices, needles,and methods for suturing tissue and prosthetic devices such as, but notlimited to, papillary muscles, aortic roots, and annuloplasty rings.

BACKGROUND

The human heart relies on a series of one-way valves to help control theflow of blood through the chambers of the heart. For example, referringto FIG. 1 , deoxygenated blood returns to the heart 20, via the superiorvena cava 22 and the inferior vena cava 24, entering the right atrium26. The heart muscle tissue contracts in a rhythmic, coordinatedheartbeat, first with an atrial contraction which aids blood in theright atrium 26 to pass through the tricuspid valve 28 and into theright ventricle 30. Following atrial contraction, ventricularcontraction occurs and the tricuspid valve 28 closes. Ventricularcontraction is stronger than atrial contraction, assisting blood flowthrough the pulmonic valve 32, out of the heart 20 via the pulmonaryartery 34, and to the lungs (not shown) for oxygenation. Following theventricular contraction, the pulmonic valve 32 closes, preventing thebackwards flow of blood from the pulmonary artery 34 into the heart 20.

Oxygenated blood returns to the heart 20, via the pulmonary veins 36,entering the left atrium 38. Left atrial contraction assists blood inthe left atrium 38 to pass through the mitral valve 40 and into the leftventricle 42. Following the atrial contraction, ensuing ventricularcontraction causes mitral valve 40 closure, and pushes oxygenated bloodfrom the left ventricle 42 through the aortic valve 44 and into theaorta 46 where it then circulates throughout the body. Under nominalconditions, prolapse of mitral valve 40 is prevented during ventricularcontraction by chordae 40A attached between the mitral valve 40 leafletsand papillary muscles 40B. Following left ventricular contraction, theaortic valve 44 closes, preventing the backwards flow of blood from theaorta 46 into the heart 20.

Unfortunately, one or more of a person's heart valves 28, 32, 40, and 44can have or develop problems which adversely affect their function and,consequently, negatively impact the person's health. Generally, problemswith heart valves can be organized into two categories: regurgitationand/or stenosis. Regurgitation occurs if a heart valve does not sealtightly, thereby allowing blood to flow back into a chamber rather thanadvancing through and out of the heart. This can cause the heart to workharder to remain an effective pump. Regurgitation is frequently observedwhen the mitral valve 40 fails to properly close during a ventricularcontraction. Mitral regurgitation can be caused by chordae 40Astretching, tearing, or rupturing, along with other structural changeswithin the heart.

Neochordal replacement for stretched or torn chordae is one option toreduce regurgitation. In such a procedure, chords to be replaced areidentified and dissected as required. A papillary suture is placed in apapillary muscle corresponding to the dissected chord. The papillarysuture may optionally be pledgeted on one or both sides of the papillarymuscle. A leaflet suture is also placed in the corresponding mitralvalve leaflet. The papillary suture and the leaflet suture may then betied or otherwise fastened together to create a replacement chord tohelp support the mitral valve leaflet and prevent regurgitation.

Regurgitation with the mitral valve or the aortic valve may also occurwhen the valve's leaflets are unable to coapt properly. In such asituation, if the leaflets are still viable, surgeons may determine thatthe improper coaption is caused by changes in the surrounding annulustissue whereby the annulus has become distorted due to disease orpatient genetics/aging. One possible treatment in such situations is avalve annuloplasty, whereby a device (typically a ring) is suturedaround the heart valve to help pull the valve leaflets together.

In cases of stenosis, when a heart valve does not fully patent due tostiff or fused leaflets, blood flow tract narrowing, or obstructivematerial buildup (e.g., calcium), installation of a replacement heartvalve may be more appropriate. In these situations, the diseased heartvalve may be removed and then a replacement valve may be sutured intothe surrounding tissue.

Unfortunately, while many of the above techniques are proven methods ofheart valve repair, technical challenges impede their widespreadutilization, especially in minimally invasive cardiac surgery. Inparticular, it is difficult and time consuming to manipulate a sutureneedle with forceps through a minimally invasive opening to place thesutures for neochordal replacement, valve annuloplasty, or valvereplacement. An innovative system that remotely delivers and reliablysecures suture for a variety of surgical situations would dramaticallyimprove the accessibility and clinical outcomes following cardiac andother types of surgery.

Therefore, there is a need for an efficient and precise minimallyinvasive surgical suturing device that enables surgeons to utilize aminimal invasive entry point for cardiac and other procedures withoutsacrificing suturing effectiveness.

SUMMARY

A suturing device needle is disclosed. The needle includes a flywheelportion. The needle also includes at least one curved arm extending fromthe flywheel portion, the at least one curved arm comprising a ferruleengaging tip at an end of the at least one curved arm away from theflywheel portion.

Another suturing device needle is disclosed. The needle includes aflywheel portion. The flywheel portion defines 1) a needle pivot axis;2) an actuator coupler, wherein the actuator coupler is accessible in afirst direction parallel to the needle pivot axis and accessible in asecond direction perpendicular to the needle pivot axis; and 3) anactuator access slot in communication with the actuator coupler. Theneedle also includes a first curved arm extending from the flywheelportion. The first curved arm includes 1) a first ferrule engaging tipat an end of the first curved arm away from the flywheel portion; 2) afirst substantially constant arc with a first arc center point thatsubstantially falls on the needle pivot axis; and 3) a first releaseramp adjacent to the first ferrule engaging tip. The needle furtherincludes a second curved arm extending from the flywheel portion. Thesecond curved arm includes 1) a second ferrule engaging tip at an end ofthe second curved arm away from the flywheel portion; 2) a secondsubstantially constant arc with a second arc center point thatsubstantially falls on the needle pivot axis, wherein the first andsecond substantially constant arcs are congruent; and 3) a secondrelease ramp adjacent to the second ferrule engaging tip.

A further suturing device needle is disclosed. The needle includes aflywheel portion. The flywheel portion defines 1) a needle pivot axis;2) an actuator coupler, wherein the actuator coupler is accessible in afirst direction parallel to the needle pivot axis and accessible in asecond direction perpendicular to the needle pivot axis; and 3) anactuator access slot in communication with the actuator coupler. Theneedle also includes a curved arm extending from the flywheel portion.The curved arm has 1) a ferrule engaging tip at an end of the curved armaway from the flywheel portion; 2) a substantially constant arc with anarc center point that substantially falls on the needle pivot axis; and3) a release ramp adjacent to the ferrule engaging tip.

A suturing device for minimally invasive surgery is also disclosed. Thesuturing device has a head defining one or more ferrule holders and atissue bite area. The suturing device also has a first needle comprisinga flywheel portion and one or more curved arms extending from theflywheel portion, each of the one or more curved arms comprising aferrule engaging tip, wherein the first needle is pivotably coupled tothe head. The suturing device further has a first actuator coupled tothe first needle and configured to rotate it from a retracted position,where the ferrule engaging tip of each of the one or more curved armsstarts away from the one or more ferrule holders, through the tissuebite area, and to an engaged position where the ferrule engaging tip ofeach of the one or more curved arms is operationally aligned with theone or more ferrule holders.

Another suturing device for minimally invasive surgery is disclosed. Thesuturing device has a head defining first and second ferrule holders anda tissue bite area. The suturing device also has a needle pivotablycoupled to the head. The needle includes 1) a flywheel portion, 2) afirst curved arm extending from the flywheel portion, the first curvedarm comprising a first ferrule engaging tip; and 3) a second curved armextending from the flywheel portion, the second curved arm comprising asecond ferrule engaging tip. The suturing device further includes anactuator coupled to the needle and configured to rotate it from: 1) aretracted position where the first and second ferrule engaging tipsstart away from the first and second ferrule holders; 2) then throughthe tissue bite area; and 3) then to an engaged position where i) thefirst ferrule engaging tip is operationally aligned with the firstferrule holder; and ii) the second ferrule engaging tip is operationallyaligned with the second ferrule holder.

A re-arming tool for a surgical suturing device is also disclosed. There-arming tool includes a needle ramp having a leading edge; a needlefacing surface; and a trailing edge that is biased away from the needlefacing surface. The re-arming tool also has a positioning frame coupledto the needle ramp.

Another re-arming tool for a surgical suturing device is disclosed. There-arming tool includes a positioning frame and a needle ramp. Theneedle ramp is coupled to and biased away from the positioning frame.The needle ramp has a leading edge, a needle facing surface, and atrailing edge.

A further re-arming tool for a surgical suturing device is disclosed.The re-arming tool includes a positioning frame. The re-arming tool alsoincludes a needle ramp coupled to the positioning frame and comprising aneedle facing surface and a leading edge. The re-arming tool furtherincludes a trailing edge biased in a direction away from theneedle-facing surface of the needle ramp.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a heart, illustrating the chambersand valves which function therein.

FIG. 2 is a perspective view of one embodiment of a surgical suturingdevice.

FIG. 3 is an exploded perspective view of the embodied surgical suturingdevice of FIG. 2 without the housing or needle actuator.

FIGS. 4A-4F show front, right side, left side, top, bottom, and rearviews, respectively, for one embodiment of a needle for a surgicalsuturing device.

FIGS. 5A-5C illustrate the distal end of the surgical suturing device ofFIG. 2 in a partially sectioned perspective view, loaded with a suture,and illustrating the movement of the needle from a retracted position toan engaged position and back to the retracted position.

FIGS. 6A-6C illustrate the distal end of the surgical suturing device ofFIG. 2 in a partially sectioned side view, loaded with a suture, andillustrating the movement of the needle from a retracted position to anengaged position and back to the retracted position.

FIGS. 7A-7E illustrate a method of using an embodiment of the surgicalsuturing device from FIG. 2 to place a suture in a papillary muscle.

FIGS. 7F-7G illustrate a method of coupling a first suture placed in apapillary muscle and a second suture placed in a valve leaflet to eachother using a mechanical fastener to replace a chordae tendinae of theheart.

FIG. 8 is a perspective view of another embodiment of a surgicalsuturing device.

FIG. 9 is an exploded perspective view of the embodied surgical suturingdevice of FIG. 8 without the housing or needle actuator.

FIGS. 10A-10F show front, right side, left side, top, bottom, and rearviews, respectively, for another embodiment of a needle for a surgicalsuturing device.

FIGS. 11A-11C illustrate the distal end of the surgical suturing deviceof FIG. 8 in a partially sectioned perspective view, loaded with asuture, and illustrating the movement of the needle from a retractedposition to an engaged position and back to the retracted position.

FIGS. 12A-12C illustrate the distal end of the surgical suturing deviceof FIG. 8 in a partially sectioned side view, loaded with a suture, andillustrating the movement of the needle from a retracted position to anengaged position and back to the retracted position.

FIGS. 13A-13G illustrate a method of using an embodiment of the surgicalsuturing device from FIG. 8 to place a pledgeted suture in a valveannulus which has had its diseased valve leaflets removed.

FIGS. 13H-13I illustrate a method of coupling multiple sutures placed ina valve annulus to the sewing cuff of a replacement heart valve usingmechanical fasteners as part of a heart valve replacement procedure.

FIG. 14 is a perspective view of a further embodiment of a surgicalsuturing device.

FIG. 15 is an exploded perspective view of the embodied surgicalsuturing device of FIG. 14 without the housing or needle actuator.

FIGS. 16A-16F show front, right side, left side, top, bottom, and rearviews, respectively, for a further embodiment of a needle for a surgicalsuturing device.

FIG. 17 illustrates the distal end of the surgical suturing device ofFIG. 14 in a partially sectioned perspective view.

FIGS. 18A-18C illustrate the distal end of the surgical suturing deviceof FIG. 14 in a partially sectioned side view, loaded with a suture, andillustrating the movement of the needle from a retracted position to anengaged position and back to the retracted position.

FIGS. 18D-18F illustrate the distal end of the surgical suturing deviceof FIG. 14 in a partially sectioned side view, where theferrule-engaging tip of the curved arm is initially coupled to a sutureferrule, and illustrating the movement of the needle from a retractedposition to an engaged position and back to the retracted position inorder to deposit the suture ferrule back in a ferrule holder.

FIGS. 19A-19H illustrate a method of using an embodiment of the surgicalsuturing device from FIG. 14 to place a suture through an annuloplastyring and underlying tissue.

FIGS. 19I-19J illustrate a method of coupling a first suture and thenmultiple sutures placed in an annuloplasty ring and underlying tissue tothe ring as part of an annuloplasty.

FIGS. 20A and 20B schematically illustrate another embodiment of asurgical suturing device in top and side views, respectively, thisembodiment having a needle with multiple pairs of curved arms, each pairof curved arms following a path having a different radius.

FIGS. 21A and 21B schematically illustrate a resultant placement ofsutures in tissue from the surgical suturing device of FIGS. 20A and20B.

FIGS. 22A and 22B schematically illustrate a further embodiment of asurgical suturing device in top and side views, respectively, thisembodiment having a needle with multiple pairs of curved arms, each pairof curved arms following paths having substantially the same radius.

FIGS. 23A and 23B schematically illustrate a resultant placement ofsutures in tissue from the surgical suturing device of FIGS. 22A and22B.

FIGS. 24A and 24B schematically illustrate another embodiment of asurgical suturing device in top and side views, respectively, thisembodiment having a plurality of needles, each needle having a pair ofcurved arms configured to engage in a direction opposite the other pairand following paths having a different radius from the other pair.

FIGS. 25A and 25B schematically illustrate a resultant placement ofsutures in tissue from the surgical suturing device of FIGS. 24A and24B.

FIGS. 26A and 26B schematically illustrate a further embodiment of asurgical suturing device in top and side views, respectively, thisembodiment having a plurality of needles, including a central needlehaving a pair of curved arms and two outer needles, each outer needlehaving its own curved arm configured to engaging in a direction oppositefrom the pair of curved arms on the central needle, but havingsubstantially the same radius.

FIGS. 27A and 27B schematically illustrate a resultant placement ofsutures in tissue from the surgical suturing device of FIGS. 26A and26B.

FIGS. 28A and 28B illustrate another embodiment of a surgical suturingdevice having a needle with one or more curved arms whereby the pivotaxis of the needle and the centerpoint of the arc of the curved arms donot coincide.

FIGS. 29A-29N illustrate another method of suturing an annuloplasty ringto underlying tissue using the surgical suturing device of FIG. 14 .

FIG. 30 is a perspective view of one embodiment of a re-arming tool fora surgical suturing device.

FIGS. 31A-31C are partial cross-sectional side views of a surgicalsuturing device being re-armed with the re-arming tool of FIG. 30 .

FIGS. 32A-32J illustrate another method of replacing a chordae tendinaeof the heart using the surgical suturing device of FIG. 2 .

It will be appreciated that for purposes of clarity and where deemedappropriate, reference numerals have been repeated in the figures toindicate corresponding features, and that the various elements in thedrawings have not necessarily been drawn to scale in order to bettershow the features.

DETAILED DESCRIPTION

FIG. 2 is a perspective view of one embodiment of a surgical suturingdevice 48. The surgical suturing device 48 has a device tip 50 which islocated at a distal end 52 of a shaft 54 and which will be discussed inmore detail below. The surgical suturing device 48 also has an actuator56 which is coupled to an actuator rod 58. The actuator 56 has anactuator pivot point 60 supported by a housing 62. An actuator spring 63is coupled between the actuator 56 and the housing 62 to bias theactuator 56 into a retracted position, such as the position shown inFIG. 2 . In this embodiment, a handle 64 of the actuator 56 isconfigured to be moved from the retracted position of FIG. 2 to anengaged position where the actuator 56 is pivoted around the pivot point60 to move the handle 64 closer to a grip 65 of the housing 64. Sincethe pivot point 60 is between the handle 64 and the point where theactuator rod 58 couples to the actuator 56 in this embodiment, theactuator rod 58 will move distally, toward the device tip 50 when thehandle 64 is squeezed towards the grip 65. Conversely, in thisembodiment, the actuator rod 58 will move proximally, toward the housing62, when the handle 64 is moved away from the grip 65. Although theactuator 56 in this embodiment includes a lever, other embodiments mayutilize a variety of other actuators, including, but not limited to, acontrol knob, a control wheel, a solenoid, a slider, a screw, one ormore gears, one or more pulleys, a motor, or any plurality and/orcombination thereof.

FIG. 3 is an exploded perspective view of the embodied surgical suturingdevice of FIG. 2 without the housing or needle actuator. The device tip50 includes a head 66 having a first opening 67 through which a ferrulerelease feature 68 may be inserted. The actuator rod 58 has an actuatorend effector 70 coupled to a distal end of the actuator rod 58. Theactuator end effector 70 may be inserted into an actuator coupler 72defined by a needle 74. The needle 74 may be inserted into a needleaccess hole 76 in a side of the head 66 opposite the first opening 67,while the actuator rod 58 may be positioned within an actuator accesschannel 78 also defined by the head 66. The actuator rod 58 will extendout of the head 66 and can be fitted within an actuator rod guide 80which fits within the shaft 54. Other embodiments may forego an actuatorrod guide 80, and may instead just use the shaft 54 to contain theactuator rod 58. The head 66 couples to the shaft 54.

The needle 74 also defines a needle pivot axis 82 which may be alignedwith one or more holes 84 in the head 66. The needle pivot axis 82 maybe kept in alignment with the one or more holes 84 by a pivot pin 86which can be inserted into the one or more holes 84 and the needle pivotaxis 82. The exploded assembly of the embodiment in FIG. 3 is just oneof many possible assemblies, and it should be understood that thoseskilled in the art will realize other assembly configurations andmethods of assembly which can produce the claimed surgical suturingdevice and its equivalents. Such assembly methods and their equivalentsare intended to be included in the scope of this disclosure.

FIGS. 4A-4F show front, right side, left side, top, bottom, and rearviews, respectively, for one embodiment of a needle 74 for a surgicalsuturing device. As noted earlier, in this embodiment, the needle 74defines an actuator coupler 72 and a needle pivot axis 82. In thisembodiment, the needle pivot axis 82 is a cylindrical channel in theneedle through which an axle pin may be inserted. In other embodiments,the needle pivot axis 82 may be defined by protrusions on one or moreside of the needle 74. The needle 74 also has a flywheel portion 87which will be discussed in more detail below.

In this embodiment, the needle 74 has first and second curved arms 88and 92 extending from the flywheel portion 87. The first curved arm 88has a first ferrule engaging tip 90 at an end of the first curved arm 88away from the flywheel portion 87. Likewise, the second curved arm 92has a second ferrule engaging tip 94 at an end of the second curved arm92 away from the flywheel portion 87. The first and second ferruleengaging tips 90, 94 and their respective curved arms 88, 92 areconfigured to be able to pierce tissue as the needle 74 is rotated aboutthe needle pivot axis 82. The first and second ferrule engaging tips 90,94 are each further configured to releasably engage a ferrule attachedto suture (not shown here, as the needle does not include any ferrules).

In this embodiment, the first and second curved arms 88, 92 each extendfrom the flywheel portion 87 on substantially identical arcs followingsubstantially parallel paths. Furthermore, in this embodiment, the firstand second curved arms 88, 92 each have a respective arc centerpointwhich falls on the needle pivot axis 82. Also, in this embodiment, eachof the first and second curved arms 88, 92 has a substantially squarecross-section. Other embodiments may have other cross-sectional shapes,including, but not limited to substantially round cross-sections orsubstantially triangular cross-sections.

In this embodiment, the first curved arm 88, of needle 74, also includesa first release ramp 96 adjacent to the first ferrule engaging tip 90.Similarly, the second curved arm 92 also includes a second release ramp98 adjacent to the second ferrule engaging tip 94. The first and secondrelease ramps 96, 98 enable a portion of a ferrule release feature (notshown here, since it is not part of the needle) to be biased against thefirst and second curved arms 88, 92, and depending on a rotationalposition of the needle 74, the ferrule release feature can ride up thefirst and second release ramps 96, 98 to push a ferrule off of each ofthe first and second ferrule engaging tips 90, 94.

As noted above, the flywheel portion 87 defines an actuator coupler 72.In this embodiment, the actuator coupler 72 is accessible in a firstdirection, parallel to the pivot axis 82 of the needle 74. This accessto the actuator coupler 72 in the first direction may be seen in theviews of FIGS. 4A and 4F. The actuator coupler 72 is also accessible ina second direction, perpendicular to the pivot axis 82 of the needle 74.In this embodiment, the flywheel portion 87 also defines an actuatoraccess slot 100 which also facilitates access to the actuator coupler 72in the second direction. Access to the actuator coupler 72 may beimportant in some embodiments so that the actuator end effector on theactuator rod (neither item shown here, since they are not part of theneedle) may be coupled to the needle 74 and so that the actuator (viathe actuator rod in this example) can rotate the needle 74.

The needle 74 may be made from a variety of materials, including, butnot limited to one or more metals, alloys, plastics, polymers, types ofglass, ceramics, silicon, and any combination and/or plurality thereof.The flywheel portion 87 of the needle 74 adds mass to the needle to helpensure a smooth rotational needle movement and to help control theorientation of the needle as it moves through tissue by stabilizing theneedle 74 against one or more inside surfaces of the device head. Inmany embodiments, the mass of the flywheel portion 87 may be greaterthan or equal to the mass of the one or more curved arms 88, 92 of theneedle 74. In other embodiments, the mass of the flywheel portion 87 maybe less than the mass of the one or more curved arms 88, 92 of theneedle 74. Without being tied to one specific theory, the mass of theflywheel portion 87 can also eliminate the need for a guide for thecurved arms 88, 92 since the needle 74 may be stabilized by the mass anddimensions of the flywheel portion 87. As can be seen in the views ofFIGS. 4A and 4F, the flywheel portion 87 sweeps across an arc ofapproximately ninety degrees in addition to helping define the needlepivot axis 82. Other embodiments may include one or more arc sweeps oflesser, greater, or similar size. As can be seen in the views of FIGS.4B, 4C, 4D, and 4E, the flywheel portion 87 also has a width whichreaches between the two curved arms 88, 92. In other embodiments, theflywheel portion may have thinner or wider widths. The flywheel portion87 may also include a tissue-engaging portion as will be discussed inthe examples below.

FIGS. 5A-5C show the distal end of the surgical suturing device of FIG.2 in a partially sectioned perspective view, illustrating the movementof the needle 74. FIG. 5A corresponds to FIG. 6A, FIG. 5B corresponds toFIG. 6B, and FIG. 5C corresponds to FIG. 6C. In FIG. 5A, the needle 74is shown in a retracted position, where the first ferrule engaging tip90 and the second ferrule engaging tip (not visible in this view) startaway from their respective first and second ferrule holders 102, 104.The ferrule holders 102, 104 are either formed from or coupled to thedevice head 66. A first ferrule 106 and a second ferrule 108 are eachinstalled in and held by respective first and second ferrule holders102, 104. The first ferrule 106 is coupled to a first end 110 of asuture 114, while the second ferrule 108 is coupled to a second end 112of the suture 114. The suture 114 may be of a variety of lengths, andfor convenience the portion of the suture 114 where it loops back onitself is not shown. It should be understood that the term “suture”, asused herein, is intended to cover any thread, cable, wire, filament,strand, line, yarn, gut, or similar structure, whether natural and/orsynthetic, in monofilament, composite filament, or multifilament form(whether braided, woven, twisted, or otherwise held together), as wellas equivalents, substitutions, combinations, and pluralities thereof forsuch materials and structures.

The head 66, along with a tissue engaging surface 115 of the flywheelportion of the needle 74, defines a tissue bite area 124. In thisembodiment, as can be better seen in FIG. 6A, the tissue bite area 124faces a direction which is substantially perpendicular to a longitudinalaxis 125 of the shaft 54.

As shown in FIGS. 5B and 6B, the actuator rod 58 may be moved in adistal direction 116, which will cause the needle 74 to rotate in afirst direction 118 about its needle pivot axis. While rotating in thisfirst direction 118, the ferrule engaging tips 90, 94 of the curved arms88, 92 pass from their retracted position (shown in FIGS. 5A, 6A),through the tissue bite area 124, and to an engaged position (shown inFIGS. 5B, 6B). In this embodiment, the ferrule engaging tips 90, 94 movealong an arcuate path from a distal end of the head 66 towards aproximal side of the head 66. In the engaged position of FIGS. 5B, 6B,the ferrule engaging tips 90, 94 are each coupled to correspondingferrules 106, 108 by an interference fit or alternate attachmentmechanism, the choice of which is known to those skilled in the art.This coupling of the ferrule engaging tips 90, 94 with the correspondingferrules 106, 108 may be referred to as operational alignment.

As shown in FIGS. 5C and 6C, the actuator rod 58 may be moved in aproximal direction 120, which will cause the needle 74 to rotate in asecond direction 122 (opposite the first direction 118) about its needlepivot axis. While rotating in this second direction 122, the ferruleengaging tips 90, 94 of the curved arms 88, 92 (and the ferrules 106,108 which are coupled to them) pass from their engaged position (shownin FIGS. 5B and 6B), back through the tissue bite area 124, and to theretracted position as shown in FIGS. 5C and 6C. In this embodiment,while moving back to the retracted position, the ferrule engaging tips90, 94 move along an arcuate path from the proximal side of the head 66to the distal side of the head 66. Depending on the embodiment, if aferrule release feature 68 is present in the device, the ferrule releasefeature 68 may have elements which are positioned to ride against thecurved arms, up the release ramps of the curved arms, and against theferrules 106, 108 to remove the ferrules 106, 108 from the ferruleengaging tips 90, 94 when the tips 90, 94 return to the retractedposition. In other embodiments, the actuator 58 may be configured toselectively rotate the needle past the retracted position, away from theengaged position, when desired in order to then force the capturedferrules to engage the ferrule release feature 68. Some embodiments maynot include a ferrule release feature at all.

FIGS. 7A-7E illustrate a method of using an embodiment of the surgicalsuturing device from FIG. 2 to place a suture in a papillary muscle 40B.FIG. 7A schematically illustrates a surgical situation. Minimallyinvasive access has been gained to the left ventricle of the heart. Apathologic chord has been removed from the illustrated papillary muscle40B, and the suturing device 48 is ready to be used. For convenience,the handle, actuator, and entire shaft are not shown in these views. Asbefore, the device 48 has a tissue bite area 124 defined at least inpart by the head 66 at the end of the shaft 54. First and secondferrules 106, 108, coupled to the ends of suture 114 are held in ferruleholders on the proximal side of the tissue bite area 124 in the devicehead 66. The first and second curved arms 88, 92 and their respectivefirst and second ferrule engaging tips 90, 94 are in a retractedposition on the distal side of the tissue bite area 124.

As shown in FIG. 7B, the tissue bite area 124 is placed over thepapillary muscle 40B. As shown in FIG. 7C, the needle is actuated sothat the first and second curved arms 88, 92, and their respectiveferrule engaging tips, pass through the papillary muscle in the tissuebite area and engage the corresponding first and second ferrules 106,108. As shown in FIG. 7D, the needle is actuated so that the first andsecond curved arms 88, 92 and their respective ferrule engaging tips andthe respective ferrules 106, 108 held by those ferrule engaging tips arepulled back through the tissue 40B in the tissue bite area and into aretracted position again. Since the ends of suture 114 are coupled tothe ferrules 106, 108, the suture 114 is also pulled through thepapillary muscle 40B. As illustrated in FIG. 7E, the suturing device 48may be pulled away 126 from the papillary muscle 40B in order to take upthe slack in the suture 114. Although this embodiment does notillustrate the use of a pledget on the suture 114, other embodiments mayinclude a pledget which was pre-installed on the suture 114. Theferrules 106, 108 may be removed from the suture.

FIGS. 7F-7G illustrate a method of coupling a first suture 114 placed ina papillary muscle 40B and a second suture 128 placed in a valve leaflet130 to each other using a mechanical fastener 136 to replace a chordaetendinae of the heart. FIG. 7F simply shows the second suture 128 afterit has been stitched through a leaflet 130 of the mitral valve 40. Thoseskilled in the art will be familiar with a variety of ways to createthis stitch of the second suture 128. FIG. 7G illustrates a mechanicalfastener 136 which has been fastened to hold a first set of suture ends110, 112 of the first suture 114 which have been passed up through themechanical faster 136. The mechanical fastener 136 also holds a secondset of suture ends 132, 134 of the second suture 128 which have beenpassed down through the mechanical fastener 136. One suitable method forfastening the two sets of suture ends together in this fashion isdisclosed in U.S. Patent Application Publication 2014/0276979, publishedSep. 18, 2014 for U.S. patent application Ser. No. 13/840,481 filed Mar.15, 2013, the entirety of which is hereby incorporated by reference.

FIG. 8 is a perspective view of another embodiment of a surgicalsuturing device 138. The surgical suturing device 138 has a device tip140 which is located at a distal end 142 of a shaft 144 and which willbe discussed in more detail below. The surgical suturing device 138 alsohas an actuator 146 which is coupled to an actuator rod 148. Theactuator 146 has an actuator pivot point 150 supported by a housing 152.An actuator spring 153 is coupled between the actuator 146 and thehousing 152 to bias the actuator 146 into a retracted position, such asthe position shown in FIG. 8 . In this embodiment, a handle 154 of theactuator 146 is configured to be moved from the retracted position ofFIG. 8 to an engaged position where the actuator 146 is pivoted aroundthe pivot point 150 to move the handle 154 closer to a grip 155 of thehousing 152. Since the point where the actuator rod 148 couples to theactuator 146 is between the handle 154 and the pivot point 150 in thisembodiment, the actuator rod 148 will move proximally, away from thedevice tip 140 when the handle 154 is squeezed towards the grip 155.Conversely, in this embodiment, the actuator rod 148 will move distally,toward the device tip 140, when the handle 154 is moved away from thegrip 155. Although the actuator 146 in this embodiment includes a lever,other embodiments may utilize a variety of other actuators, including,but not limited to, a control knob, a control wheel, a solenoid, aslider, a screw, one or more gears, one or more pulleys, a motor, or anyplurality and/or combination thereof.

FIG. 9 is an exploded perspective view of the embodied surgical suturingdevice of FIG. 8 without the housing or needle actuator. The device tip140 includes a head 160 having a first opening 161 through which aferrule release feature 156 may be inserted and held in place with a pin158. The actuator rod 148 may be passed through an actuator rod guide162 which is sized to fit within shaft 144. The actuator rod 148 alsopasses through an actuator access channel 164 defined by the head 160.The actuator rod 148 may then temporarily be passed out through a needleaccess hole 166 defined in the head 160 opposite the first opening 161.The actuator rod 148 can then be passed through an actuator access slot168 defined by a needle 176 and into a receiving hole 170 of an actuatorend effector 172 which fits within an actuator coupler 174 also definedby the needle 176. The actuator rod 148 is coupled to the actuator endeffector 172. The needle 176 may be inserted into the needle access hole166 and the head 160 couples to the shaft 144.

The needle 176 also defines a needle pivot axis 178 which may be alignedwith one or more holes 180 in the head 160. The needle pivot axis 178may be kept in alignment with the one or more holes 180 by a pivot pin182 which can be inserted into the one or more holes 180 and the needlepivot axis 178. The exploded assembly of the embodiment in FIG. 9 isjust one of many possible assemblies, and it should be understood thatthose skilled in the art will realize other assembly configurations andmethods of assembly which can produce the claimed surgical suturingdevice and its equivalents. Such assembly methods and their equivalentsare intended to be included in the scope of this disclosure.

FIGS. 10A-10F show front, right side, left side, top, bottom, and rearviews, respectively, for one embodiment of a needle 176 for a surgicalsuturing device. As noted earlier, in this embodiment, the needle 176defines an actuator coupler 174 and a needle pivot axis 178. In thisembodiment, the needle pivot axis 178 is a cylindrical channel in theneedle through which an axle pin may be inserted. In other embodiments,the needle pivot axis may be defined by protrusions on one or more sidesof the needle 176. The needle 176 also has a flywheel portion 183 whichwill be discussed in more detail below.

In this embodiment, the needle 176 has first and second curved arms 184and 188 extending from the flywheel portion 183. The first curved arm184 has a first ferrule engaging tip 186 at an end of the first curvedarm 184 away from the flywheel portion 183. Likewise, the second curvedarm 188 has a second ferrule engaging tip 190 at an end of the secondcurved arm 188 away from the flywheel portion 183. The first and secondferrule engaging tips 186, 190 and their respective curved arms 184, 188are configured to be able to pierce tissue as the needle 176 is rotatedabout the needle pivot axis 178. The first and second ferrule engagingtips 186, 190 are each further configured to releasably engage a ferruleattached to suture (not shown here, as the needle does not include anyferrules).

In this embodiment, the first and second curved arms 184, 188 eachextend from the flywheel portion 183 on substantially identical arcsfollowing substantially parallel paths. Furthermore, in this embodiment,the first and second curved arms 184, 188 each have a respective arccenterpoint which falls on the needle pivot axis 178. Also, in thisembodiment, each of the first and second curved arms 184, 188 has asubstantially round cross-section. Other embodiments may have othercross-sectional shapes, including, but not limited to substantiallysquare cross-sections or substantially triangular cross-sections.

In this embodiment, the first curved arm 184, of needle 176, alsoincludes a first release ramp 192 adjacent to the first ferrule engagingtip 186. Similarly, the second curved arm 188 also includes a secondrelease ramp 194 adjacent to the second ferrule engaging tip 190. Thefirst and second release ramps 192, 194 enable a portion of a ferrulerelease feature (not shown here, since it is not part of the needle) tobe biased against the first and second curved arms 184, 188, anddepending on a rotational position of the needle 176, the ferrulerelease feature can ride up the first and second release ramps 192, 194to push a ferrule off of each of the first and second ferrule engagingtips 186, 190.

As noted above, the flywheel portion 183 defines an actuator coupler174. In this embodiment, the actuator coupler 174 is accessible in afirst direction, parallel to the pivot axis 178 of the needle 176. Thisaccess to the actuator coupler 174 in the first direction may be seen inthe views of FIGS. 10A and 10F. The actuator coupler 174 is alsoaccessible in a second direction, perpendicular to the pivot axis 178 ofthe needle 176. In this embodiment, the flywheel portion 183 alsodefines an actuator access slot 168 which also facilitates access to theactuator coupler 174 in the second direction. Access to the actuatorcoupler 174 may be important in some embodiments so that the actuatorend effector on the actuator rod (neither item shown here, since theyare not part of the needle) may be coupled to the needle 176 and so thatthe actuator (via the actuator rod in this example) can rotate theneedle 176.

As with the previous example, the needle 176 may be made from a varietyof materials, including, but not limited to one or more metals, alloys,plastics, polymers, types of glass, ceramics, silicon, and anycombination and/or plurality thereof. The flywheel portion 183 of theneedle 176 adds mass to the needle to help ensure a smooth rotationalneedle movement and to help control the orientation of the needle as itmoves through tissue by stabilizing the needle 176 against one or moreinside surfaces of the device head. In many embodiments, the mass of theflywheel portion 183 may be greater than or equal to the mass of the oneor more curved arms 184, 188 of the needle 176. In other embodiments,the mass of the flywheel portion 183 may be less than the mass of theone or more curved arms 184, 188 of the needle 176. Without being tiedto one specific theory, the mass of the flywheel portion 183 can alsoeliminate the need for a guide for the curved arms 184, 188 since theneedle 176 may be stabilized by the mass and dimensions of the flywheelportion 183. As can be seen in the views of FIGS. 10A and 10F, theflywheel portion 183 sweeps across an arc of approximately ninetydegrees in addition to helping define the needle pivot axis 178. Otherembodiments may include one or more arc sweeps of lesser, greater, orsimilar size. As can be seen in the views of FIGS. 10B, 10C, 10D, and10E, the flywheel portion 183 also has a width which reaches between thetwo curved arms 184, 188. In other embodiments, the flywheel portion 183may have thinner or wider widths. The flywheel portion 183 may alsoinclude a tissue-engaging portion as will be discussed in the examplesbelow.

FIGS. 11A-11C show the distal end of the surgical suturing device ofFIG. 8 in a partially sectioned perspective view, illustrating themovement of the needle 176. FIG. 11A corresponds to FIG. 12A, FIG. 11Bcorresponds to FIG. 12B, and FIG. 11C corresponds to FIG. 12C. In FIG.11A, the needle 176 is shown in a retracted position, where the firstferrule engaging tip 186 and the second ferrule engaging tip (notvisible in this view) start away from their respective first and secondferrule holders 196, 198. The ferrule holders 196, 198 are either formedfrom or coupled to the device head 160. A first ferrule 200 and a secondferrule 202 are each installed in and held by respective first andsecond ferrule holders 196, 198. The first ferrule 200 is coupled to afirst end 204 of a suture 208, while the second ferrule 202 is coupledto a second end 206 of the suture 208. The suture 208 may be of avariety of lengths, and for convenience the portion of the suture 208where it loops back on itself is not shown. As before, it should beunderstood that the term “suture”, as used herein, is intended to coverany thread, cable, wire, filament, strand, line, yarn, gut, or similarstructure, whether natural and/or synthetic, in monofilament, compositefilament, or multifilament form (whether braided, woven, twisted, orotherwise held together), as well as equivalents, substitutions,combinations, and pluralities thereof for such materials and structures.

The head 160, along with a tissue engaging surface 209 of the flywheelportion of the needle 176, define a tissue bite area 218. In thisembodiment, as can be better seen in FIG. 12A, the tissue bite area 218faces a direction which is substantially oblique to a longitudinal axis219 of the shaft 144.

As shown in FIGS. 11B and 12B, the actuator rod 148 may be moved in aproximal direction 210, which will cause the needle 176 to rotate in afirst direction 212 about its needle pivot axis. While rotating in thisfirst direction 212, the ferrule engaging tips 186, 190 of the curvedarms 184, 188 pass from their retracted position (shown in FIGS. 11A,12A), through the tissue bite area 218, and to an engaged position(shown in FIGS. 11B, 12B). In this embodiment, the ferrule engaging tips186, 190 move along an arcuate path from a proximal side of the head 160towards a distal end of the head 160. In the engaged position of FIGS.11B, 12B, the ferrule engaging tips 186, 190 are each coupled tocorresponding ferrules 200, 202 by an interference fit or alternateattachment mechanism, the choice of which is known to those skilled inthe art. This coupling of the ferrule engaging tips with thecorresponding ferrules may be referred to as operational alignment.

As shown in FIGS. 11C and 12C, the actuator rod 148 may be moved in adistal direction 214, which will cause the needle 176 to rotate in asecond direction 216 (opposite the first direction 212) about its needlepivot axis. While rotating in this second direction 216, the ferruleengaging tips 186, 190 of the curved arms 184, 188 (and the ferrules200, 202 which are coupled to them) pass from their engaged position(shown in FIGS. 11B and 12B), back through the tissue bite area 218, andto the retracted position as shown in FIGS. 11C and 12C. In thisembodiment, while moving back to the retracted position, the ferruleengaging tips 186, 190 move along an arcuate path from the distal end ofthe head 160 to the proximal side of the head 160. Depending on theembodiment, if a ferrule release feature 156 is present in the device,the ferrule release feature 156 may have elements which are positionedto ride against the curved arms, up the release ramps of the curvedarms, and against the ferrules 200, 202 to remove the ferrules 200, 202from the ferrule engaging tips 186, 190 when the tips 186, 190 return tothe retracted position. In other embodiments, the actuator 156 may beconfigured to selectively rotate the needle 176 past the retractedposition, away from the engaged position, when desired, in order then toforce the captured ferrules 200, 202 to engage the ferrule releasefeature 156. Some embodiments may not include a ferrule release featureat all.

FIGS. 13A-13G illustrate a method of using an embodiment of the surgicalsuturing device from FIG. 8 to place a pledgeted suture in a valveannulus which has had its diseased valve leaflets removed. FIG. 13Aschematically illustrates a diseased heart valve 220 in need ofreplacement. As a first action, a surgeon might gain access to thediseased valve 220 and dissect the leaflets of the valve, leaving theannulus 222 in preparation for installation of a replacement heart valveas shown in FIG. 13B. As illustrated in FIG. 13C, the suturing device138 is ready to be used. For convenience, the handle, actuator, andentire shaft are not shown in these views. As before, the device 138 hasa tissue bite area 218 defined at least in part by the head 160 at theend of the shaft 144. First and second ferrules 200, 202, coupled to theends of suture 208 are held in ferrule holders on the distal side of thetissue bite area 218 in the device head 160. The first and second curvedarms 184, 188 and their respective first and second ferrule engagingtips 186, 190 are in a retracted position on the proximal side of thetissue bite area 218. In this embodiment, the suture 208 is alsopledgeted with a pledget 224 pre-installed on the suture 208.

In this example, it would be desirable to attach the replacement heartvalve to the remaining annulus 222. Therefore, as illustrated in FIG.13D, the tissue bite area 218 of the surgical suturing device 138 couldbe placed over a portion of the annulus 222 where it would be desired tomake some attachment stitches.

As shown in FIG. 13E, the needle is actuated so that the first andsecond curved arms 184, 188, and their respective ferrule engaging tips,pass through the annulus 222 in the tissue bite area and engage thecorresponding first and second ferrules 200, 202. As shown in FIG. 13F,the needle is then reverse-actuated so that the first and second curvedarms 184, 188 and their respective ferrule engaging tips and therespective ferrules 200, 202 held by those ferrule engaging tips arepulled back through the annulus 222 in the tissue bite area and into aretracted position again. Since the ends of suture 208 are coupled tothe ferrules 200, 202, the suture 208 is also pulled through the annulus222. The device 138 can be pulled back 226 to tighten a portion 228 ofthe suture 208 against the pledget 224, and ultimately against theannulus 222.

The ferrules 200, 202 on the ends of the suture 208 can be released orotherwise removed. Another suture can be loaded into the device, and theprocess can be repeated around the annulus 222 as many times as desiredby the surgeon. As a simple example, FIG. 13H illustrates the result ofhaving performed the process four times with the device 138. Foursutures 208A, 208B, 208C, 208D have been placed in desired locationsthrough the annulus 222. Those four sutures 208A, 208B, 208C, 208D havealso been placed through corresponding locations in a sewing cuff 229 ofa replacement heart valve 230. Those skilled in the art are familiarwith methods of placing suture stitches in a sewing cuff 229. Eachsuture 208A, 208B, 208C, 208D passes through both the annulus 222 andthe sewing cuff 229 twice and is positioned so that it holds arespective pledget 224A, 224B, 224C, 224D against the annulus 222 andterminates in a respective pair of suture ends 232A, 232B, 232C, 232D.In practice, this process can be used for any number of sutures. Thefour sutures illustrated here are just for the convenience ofexplanation.

Tension can be maintained on the suture ends 232A, 232B, 232C, 232Dwhile the replacement valve 230 is moved down the sutures and againstthe annulus 222. Each pair of suture ends 232A, 232B, 232C, 232D canthen be tied off, knotted, clamped, or otherwise fixed against thesewing cuff 229 to hold the valve 230 in place. As one non-limitingexample, each pair of suture ends 232A, 232B, 232C, 232D may be knottedwith a mechanical knot 234A, 234B, 234C, 234D as illustrated in FIG.13I. The mechanical knots 234A, 234B, 234C, 234D may be applied, forexample, with a COR-KNOT® device available from LSI Solutions, Inc. ofVictor, N.Y. (For example, find ordering contact information atwww.lsisolutions.com). Other embodiments of mechanical knots or othertypes of knots may be used to finalize the attachment of the replacementanatomical structure.

FIG. 14 is a perspective view of one embodiment of a surgical suturingdevice 236. The surgical suturing device 236 has a device tip 238 whichis located at a distal end 240 of a shaft 242 and which will bediscussed in more detail below. The surgical suturing device 236 alsohas an actuator 244 which is coupled to an actuator rod 246. Theactuator 244 has an actuator pivot point 248 supported by a housing 250.An actuator spring 251 is coupled between the actuator 244 and thehousing 250 to bias the actuator 244 into a retracted position, such asthe position shown in FIG. 14 . In this embodiment, a handle 252 of theactuator 244 is configured to be moved from the retracted position ofFIG. 14 to an engaged position where the actuator 244 is pivoted aroundthe pivot point 248 to move the handle 252 closer to a grip 253 of thehousing 250. Since the pivot point 248 is between the handle 252 and thepoint where the actuator rod 246 couples to the actuator 244 in thisembodiment, the actuator rod 246 will move distally, toward the devicetip 238 when the handle 252 is squeezed towards the grip 253.Conversely, in this embodiment, the actuator rod 246 will moveproximally, toward the housing 250, when the handle 252 is moved awayfrom the grip 253. Although the actuator 244 in this embodiment includesa lever, other embodiments may utilize a variety of other actuators,including, but not limited to, a control knob, a control wheel, asolenoid, a slider, a screw, one or more gears, one or more pulleys, amotor, or any plurality and/or combination thereof.

FIG. 15 is an exploded perspective view of the embodied surgicalsuturing device 236 of FIG. 14 without the housing or needle actuator.The device tip 238 includes a head 254 having a first opening 256through which a first ferrule release feature 259 may be inserted. Thefirst ferrule release feature 259 may define a pivot notch 260 that canbe aligned with one or more holes 261 in the head 254. A pin 262 may beinserted into the one or more holes 261 and the pivot notch 260 to helphold the first ferrule release feature 259 in place.

A distal end of the actuator rod 246 may be coupled to an actuator endeffector 263. The actuator end effector 263 may be inserted into anactuator coupler 264 defined by a needle 266. A proximal end 268 of theactuator rod 246 and the needle 266 may be inserted into a needle accesshole 258 in a side of the head 254 opposite the first opening 256, theactuator rod 246 being positioned within an actuator access channel 270also defined by the head 254. The actuator rod 246 will extend out ofthe head 254 and can be fitted within an actuator rod guide 286 whichfits within the shaft 242. Other embodiments may forego an actuator rodguide 286, and may instead just use the shaft 242 to contain theactuator rod 246. The head 254 couples to the shaft 54.

The needle 266 also defines a needle pivot axis 272 which may be alignedwith one or more holes 274 in the head 254. The needle pivot axis 272may be kept in alignment with the one or more holes 274 by a pivot pin276 which can be inserted into the one or more holes 274 and the needlepivot axis 272. A second ferrule release feature 278 may also beinstalled through the second access hole 258 in the head 254. The secondferrule release feature 278 may define a pivot point 280, which may bealigned with one or more holes 282 in the head 254. A pivot pin 284 maybe inserted into the one or more holes 282 and through the pivot point280 to position and hold the second ferrule release feature 278. Theexploded assembly of the embodiment in FIG. 15 is just one of manypossible assemblies, and it should be understood that those skilled inthe art will realize other assembly configurations and methods ofassembly which can produce the claimed surgical suturing device and itsequivalents. Such assembly methods and their equivalents are intended tobe included in the scope of this disclosure.

FIGS. 16A-16F show front, right side, left side, top, bottom, and rearviews, respectively, for one embodiment of a needle 266 for a surgicalsuturing device. As noted earlier, in this embodiment, the needle 266defines an actuator coupler 264 and a needle pivot axis 272. In thisembodiment, the needle pivot axis 272 is a cylindrical channel in theneedle through which an axle pin may be inserted. In other embodiments,the needle pivot axis may be defined by protrusions on one or more sideof the needle 266. The needle 266 also has a flywheel portion 288 whichwill be discussed in more detail below.

In this embodiment, the needle 266 has a curved arm 290 extending fromthe flywheel portion 288. The curved arm 290 has a ferrule engaging tip292 at an end of the curved arm 290 away from the flywheel portion 288.The ferrule engaging tip 292 and its curved arm 290 are configured to beable to pierce tissue as the needle 266 is rotated about the needlepivot axis 272. The ferrule engaging tip 292 is further configured toreleasably engage a ferrule attached to suture (not shown here, as theneedle does not include any ferrules).

In this embodiment, the curved arm 290 has an arc centerpoint whichfalls on the needle pivot axis 272. In this embodiment, the curved arm290 also has a substantially square cross-section. Other embodiments mayhave other cross-sectional shapes, including, but not limited tosubstantially round cross-sections or substantially triangularcross-sections.

In this embodiment, the curved arm 290, of the needle 266, also includesa release ramp 293 adjacent to the ferrule engaging tip 292. The releaseramp 293 enables a portion of a ferrule release feature (not shown here,since it is not part of the needle) to be biased against the curved arm290 and, depending on a rotational position of the needle 266, theferrule release feature can ride up the release ramp 293 to push aferrule off of the ferrule engaging tip 292.

As noted above, the flywheel portion 288 defines an actuator coupler264. In this embodiment, the actuator coupler 264 is accessible in afirst direction, parallel to the pivot axis 272 of the needle 266. Thisaccess to the actuator coupler 264 in the first direction may be seen inthe views of FIGS. 16A and 16F. The actuator coupler 264 is alsoaccessible in a second direction, perpendicular to the pivot axis 272 ofthe needle 266. In this embodiment, the flywheel portion 288 alsodefines an actuator access slot 294 which also facilitates access to theactuator coupler 264 in the second direction. Access to the actuatorcoupler 264 may be important in some embodiments so that the actuatorend effector on the actuator rod (neither item shown here, since theyare not part of the needle) may be coupled to the needle 266 and so thatthe actuator (via the actuator rod in this example) can rotate theneedle 266.

As noted earlier, the needle 266 may be made from a variety ofmaterials, including, but not limited to one or more metals, alloys,plastics, polymers, types of glass, ceramics, silicon, and anycombination and/or plurality thereof. The flywheel portion 288 of theneedle 266 adds mass to the needle to help ensure a smooth rotationalneedle movement and to help control the orientation of the needle as itmoves through tissue by stabilizing the needle 266 against one or moreinside surfaces of the device head. In many embodiments, the mass of theflywheel portion 288 may be greater than or equal to the mass of thecurved arm 290 of the needle 266. In other embodiments, the mass of theflywheel portion 288 may be less than the mass of the curved arm 290,although this is not preferred in a single curved arm needle embodiment.Without being tied to one specific theory, the mass of the flywheelportion 288 can also eliminate the need for a guide for the curved arm290 since the needle 266 may be stabilized by the mass and dimensions ofthe flywheel portion 288. The flywheel portion 288 may also include atissue-engaging portion as will be discussed in the examples below.

FIG. 17 illustrates the distal end of the surgical suturing device ofFIG. 14 in a partially sectioned perspective view. The second ferrulerelease feature 278 may be seen. This second ferrule release feature 278pivots on pivot pin 284 and is biased by spring portion 283 to rideagainst the curved arm 290. This second ferrule release feature 278operates similarly to previously discussed ferrule release features, andis useful for releasing a ferrule and its suture from the device.

The first ferrule release feature 259 is also visible in the partiallysectioned view of FIG. 17 . The first ferrule release feature 259 pivotson pivot pin 262 and is biased away from a travel path of the curved arm290 by a spring portion 265. The first ferrule release feature 259 willnot engage the curved arm 290, unless manual button 267 is pushed intowards the head 254. The operation of the first ferrule release feature259 will be discussed in more detail below.

FIGS. 18A-18C show the distal end of the surgical suturing device ofFIG. 14 in a partially sectioned side view, illustrating the movement ofthe needle 266. In FIG. 18A, the needle 266 is shown in a retractedposition, where the ferrule engaging tip 292 starts away from itsferrule holder 288. The ferrule holder 288 is either formed from orcoupled to the device head 254. A ferrule 296 is installed in and heldby the ferrule holder 288. The ferrule 296 is coupled to a first end 298of a suture 302. A second end 300 of the suture 302 is illustrated asnot having a ferrule in this embodiment, but in some embodiments, thesecond end 300 of the suture 302 could also have a ferrule. As before,it should be understood that the term “suture”, as used herein, isintended to cover any thread, cable, wire, filament, strand, line, yarn,gut, or similar structure, whether natural and/or synthetic, inmonofilament, composite filament, or multifilament form (whetherbraided, woven, twisted, or otherwise held together), as well asequivalents, substitutions, combinations, and pluralities thereof forsuch materials and structures.

The head 254, along with a tissue engaging surface 303 of the flywheelportion of the needle 266, defines a tissue bite area 295. In thisembodiment, the tissue bite area 295 faces a direction which issubstantially parallel to a longitudinal axis 305 of the shaft 242.

As shown in FIG. 18B, the actuator rod 246 may be moved in a distaldirection 304, which will cause the needle 266 to rotate in a firstdirection 306 about its needle pivot axis. While rotating in this firstdirection 306, the ferrule engaging tip 292 of the curved arm 290 passesfrom its retracted position (shown in FIG. 18A), through the tissue bitearea 295, and to an engaged position (shown in FIG. 18B). In thisembodiment, the ferrule engaging tip 292 moves along an arcuate pathsubstantially transverse to the longitudinal axis 305 of the shaft 242.In the engaged position of FIG. 18B, the ferrule engaging tip 292 iscoupled to the ferrule 296 by an interference fit or alternateattachment mechanism, the choice of which is known to those skilled inthe art. This coupling of the ferrule engaging tips with thecorresponding ferrules may be referred to as operational alignment.

As shown in FIG. 18C, the actuator rod 246 may be moved in a proximaldirection 308, which will cause the needle 266 to rotate in a seconddirection 310 (opposite the first direction 306) about its needle pivotaxis. While rotating in this second direction 310, the ferrule engagingtip 292 of the curved arm 290 (and the ferrule 296 which is coupled toit) passes from its engaged position (shown in FIG. 18B), back throughthe tissue bite area 295, and to the retracted position as shown in FIG.18 . In this embodiment, while moving back to the retracted position,the ferrule engaging tip 292 moves along an arcuate path.

If the needle 266 is not rotated far enough for tip 312 of the secondferrule release feature 278 to remove the ferrule 296 from the ferruleengaging tip 292, a further set of actions may be taken to reset theferrule 296 and the device to their initial positions, as illustrated inFIGS. 18D-18F. As shown in FIG. 18D, the actuator rod 246 may again bemoved in a distal direction 314, which will cause the needle 266 torotate in a first direction 316 about its needle pivot axis. Whilerotating in this first direction 306, the ferrule engaging tip 292 ofthe curved arm 290 (and the ferrule 296 which is coupled to it) passesfrom its starting position (shown in FIG. 18C), through the tissue bitearea 295, and to the engaged position of FIG. 18D. The device is ideallymoved away from the tissue it may have previously had the suture passthrough prior to this step. The ferrule engaging tip 292 is stillcoupled to the ferrule 296, but the ferrule 296 is now positioned withinthe ferrule holder 288.

As illustrated in FIG. 18E, a tip 318 of the first ferrule removalfeature 259 can be caused to engage the curved arm 290 below the ferrule296 by depressing 320 the button 267 of the first ferrule removalfeature 259.

As shown in FIG. 18F, while the first ferrule removal feature 259 ismaintained in the position of FIG. 18E, the actuator rod 246 may bemoved in a proximal direction 322, which will cause the needle 266 torotate in a second direction 324 (opposite the first direction 316)about its needle pivot axis. While rotating in this second direction324, the first ferrule release feature 259 retains the ferrule 296 inthe ferrule holder 288 while the ferrule engaging tip 292 of the curvedarm 290 passes from its engaged position (shown in FIG. 18E), backthrough the tissue bite area 295 without the ferrule 296, and to theretracted position as shown in FIG. 18F. The device is now reset foranother stitch with the same suture if desired.

FIGS. 19A-19JE illustrate a method of using an embodiment of thesurgical suturing device 236 from FIG. 14 to place a suture through anannuloplasty ring and corresponding annular tissue to help restore heartvalve function. FIG. 19A schematically illustrates a surgical situation.Minimally invasive access has been gained to a chamber of the heart.Annular tissue 326 surrounding a mitral valve 40 has become enlargedand, as a result, the valve's leaflets are no longer able to maintainproper mitral valve closure. An annuloplasty ring, of a desired annulussize, may be installed over the annular tissue such that the annulartissue is snugged inward towards the prosthetic to reestablish apreferred, smaller mitral annulus. As illustrated in FIG. 19B, anannuloplasty ring 328 may be introduced into the heart and thenpositioned over the annular tissue 326 as shown in FIG. 19C. As alsoshown in FIG. 19C, the suturing device 236 is ready to be used. Forconvenience, the handle, actuator, and entire shaft are not shown inthese views. As before, the device 236 has a bite area 295 defined atleast in part by the head 254 at the end of the shaft 242. The ferrule296, coupled to the end of suture 302 is held in the ferrule holder onone side of the bite area 295 in the device head 254. The curved arm 290and its ferrule engaging tip 292 is in a retracted position on the otherside of the bite area 295.

As shown in FIG. 19D, the tissue bite area 295 is placed onto theannuloplasty ring 328 which is resting on the underlying annular tissue326. As shown in FIG. 19E, the needle is actuated so that the curved arm290 and its ferrule engaging tip 292 pass through the annuloplasty ring328, the underlying annular tissue, back up through the annuloplastyring 328, and into contact with the ferrule 296. As shown in FIG. 19F,the needle is de-actuated so that the curved arm 290 and its ferruleengaging tip 292 (along with the attached ferrule 296) are pulled backthrough the annuloplasty ring and underlying annular tissue and into aretracted position again. Since the end of suture 302 is coupled to theferrule 296, part of the suture 302 is also pulled through theannuloplasty ring and the annular tissue, too. As illustrated in FIG.19G, the suturing device 236 may be pulled away 330 from theannuloplasty ring 328, thereby drawing more of the suture 302 out of thestitch. The ferrule 296 may be removed from the suture 302, leaving thesuture 302 stitched through the annuloplasty ring 328 and the underlyingannular tissue, with two free suture ends 298, 300 protruding from theannuloplasty ring 328 as shown in FIG. 19H. As illustrated in FIG. 19I,the loose suture ends 298, 300 may be secured with a mechanical fastener332 to help hold the annuloplasty ring 328 in place. As illustrated inFIG. 19J, the suturing process may be repeated in multiple locationsaround the annuloplasty ring 328 in order to fully secure the ring 328to the underlying tissue (for example, with mechanical fasteners332A-332N each holding corresponding sutures 302A-302N).

Up until this point, the embodiments described herein have had a needlewith a maximum of one pair of curved arms. In other embodiments,however, it is possible to have a needle with more than one pair ofcurved arms. For example, FIGS. 20A and 20B schematically illustrateanother embodiment of a surgical suturing device in top and side views,respectively, this embodiment having a needle 334 with multiple pairs ofcurved arms, each pair of curved arms following an arcuate path having adifferent radius from the other pair. Needle 334 has a flywheel portion336, similar to flywheel portions described previously. The needle 334also has a first pair of curved arms 338A, 338B and a second pair ofcurved arms 340A, 340B. In this embodiment, the second pair of curvedarms 340A, 340B are located in-between the first pair of curved arms338A, 338B. As in previous embodiments, the needle 334 defines a needlepivot axis 342, and an actuator 344 is coupled to the needle 334 torotate the needle 334 about the pivot axis 342. In this embodiment, whenthe actuator 344 is moved in a direction 346 away from the needle 334,the needle rotates in a first direction 348. As the needle 334 moves inthe first direction 348, the ferrule engaging tips on each of the curvedarms 338A, 338B, 340A, 340B move on an arcuate path towardscorresponding ferrules 350A, 350B, 352A, 352B. The first pair offerrules 350A, 350B are each coupled to different ends of a first suture354, while the second pair of ferrules 352A, 352B are each coupled todifferent ends of a second suture 356. If the pairs of curved arms 338A,338B, 340A, 340B are passed through tissue, engaged with theircorresponding ferrules, and then rotated back to pull the first andsecond sutures 354, 356 through the tissue in a fashion as has beendisclosed in detail above, the resultant suture placement in tissue 358is illustrated schematically in FIGS. 21A (top view) and 21B (left sideview). Each end of the first suture 354 enters and exits the tissue 358at a distance farther from a potential incision point 360 than where theends of the second suture 356 enter and exit the same tissue 358. Due tothe difference in the arc of the first pair of curved arms 338A, 338B(larger arc) vs the second pair of curved arms 340A, 340B (smaller arc),the first suture 354 also travels deeper into the tissue 358 than thesecond suture 356 does. The suture stitches illustrated in FIGS. 21A and21B are useful for setting up a purse string suture closure prior toforming an incision therebetween so that the incision may be closedand/or drawn together as needed during a surgical procedure.

FIGS. 22A and 22B schematically illustrate a further embodiment of asurgical suturing device in top and side views, respectively, thisembodiment having a needle 362 with multiple pairs of curved arms, eachpair of curved arms following a similar arcuate path. Needle 362 has aflywheel portion 364, similar to flywheel portions described previously.The needle 362 also has a first pair of curved arms 366A, 366B and asecond pair of curved arms 368A, 368B. In this embodiment, the secondpair of curved arms 368A, 368B are located in-between the first pair ofcurved arms 366A, 366B. As in previous embodiments, the needle 362defines a needle pivot axis 370, and an actuator 372 is coupled to theneedle 362 to rotate the needle 362 about the pivot axis 370. In thisembodiment, when the actuator 372 is moved in a direction 374 away fromthe needle 362, the needle rotates in a first direction 376. As theneedle 362 moves in the first direction 376, the ferrule engaging tipson each of the curved arms 366A, 366B, 368A, 368B move on an arcuatepath towards corresponding ferrules 378A, 378B, 380A, 380B. The firstpair of ferrules 378A, 378B are each coupled to different ends of afirst suture 382, while the second pair of ferrules 380A, 380B are eachcoupled to different ends of a second suture 384. If the pairs of curvedarms 366A, 366B, 368A, 368B are passed through tissue, engaged withtheir corresponding ferrules, and then rotated back to pull the firstand second sutures 382, 384 through the tissue in a fashion as has beendisclosed in detail above, the resultant suture placement in tissue 386is illustrated schematically in FIGS. 23A (top view) and 23B (left sideview). Each end of the first suture 382 enters and exits the tissue 386at a distance farther from a potential incision point 388 than where theends of the second suture 384 enter and exit the same tissue 386. Unlikethe previous embodiment, however, since the arc of the first pair ofcurved arms 366A, 366B and the arc of the second pair of curved arms368A, 368B are substantially the same, the first and second sutures 382,384 each travel the same depth into the tissue 386. The suture stitchesillustrated in FIGS. 23A and 23B are useful for setting up a pursestring suture closure prior to forming an incision therebetween so thatthe incision may be closed and/or drawn together as needed during asurgical procedure.

Up until this point, the embodiments described herein have had a singleneedle with a varying number of curved arms. In other embodiments,however, it is possible to have multiple needles. For example, FIGS. 24Aand 24B schematically illustrate another embodiment of a surgicalsuturing device in top and side views, respectively, this embodimenthaving multiple needles 390 and 408. First needle 390 has a flywheelportion 392, similar to flywheel portions described previously. Thefirst needle 390 also has a bushing surface 393 coupled to or formed aspart of the flywheel portion 392 and configured to provide a surface forthe second needle 408 to rotate about. The first needle 390 also has apair of curved arms 394A, 394B. As in previous embodiments, the firstneedle 390 defines a needle pivot axis 396, and a first actuator rod 398is coupled to the first needle 390 to rotate the needle 390 about thepivot axis 396. In this embodiment, when the first actuator rod 398 ismoved in a direction 400 away from the first needle 390, the firstneedle 390 rotates in a first direction 402. As the first needle 390moves in the first direction 402, the ferrule engaging tips on each ofthe curved arms 394A, 394B move on an arcuate path towards correspondingferrules 404A, 404B. The first pair of ferrules 404A, 404B are eachcoupled to different ends of a first suture 406.

Similarly, second needle 408 has a flywheel portion 410, similar toflywheel portions described previously. The second needle 408 also has apair of curved arms 412A, 412B. As in previous embodiments, the secondneedle 408 defines a needle pivot axis 396, but in this embodiment, thesecond needle 408 pivots about the bushing surface 393 of the firstneedle 390. A second actuator rod 414 is coupled to the second needle408 to rotate the second needle 408 about the bushing surface 393, andtherefore, about pivot axis 396. In this embodiment, when the secondactuator rod 414 is moved in a direction 416 toward the second needle408, the second needle 408 rotates in a second direction 418. As thesecond needle 408 moves in the second direction 418, the ferruleengaging tips on each of the curved arms 412A, 412B move on an arcuatepath towards corresponding ferrules 420A, 420B. This second pair offerrules 412A, 412B are each coupled to different ends of a secondsuture 422.

If each pair of curved arms 394A, 394B and 412A, 412B are passed throughtissue (in this embodiment, in opposite directions), engaged with theircorresponding ferrules, and then rotated back to pull the first andsecond sutures 406, 422 through the tissue in a fashion as has beendisclosed in detail above, the resultant suture placement in tissue 424is illustrated schematically in FIGS. 25A (top view) and 25B (left sideview). Each end of the first suture 406 enters and exits the tissue 424at a distance farther from a potential incision point 426 than where theends of the second suture 422 enter and exit the same tissue 424. Due tothe difference in the arc of the first pair of curved arms 394A, 394B(larger arc) vs the second pair of curved arms 412A, 412B (smaller arc),the first suture 406 also travels deeper into the tissue 424 than thesecond suture 422 does. The ends of the placed sutures 406, 422 alsoface in opposite directions in this embodiment. The suture stitchesillustrated in FIGS. 25A and 25B are useful for setting up a pursestring suture closure prior to forming an incision therebetween so thatthe incision may be closed and/or drawn together as needed during asurgical procedure.

FIGS. 26A and 26B schematically illustrate a further embodiment of asurgical suturing device in top and side views, respectively, thisembodiment having multiple needles 428, 442, and 454. First needle 428has a flywheel portion 430, similar to flywheel portions describedpreviously. The first needle 428 has a single curved arm 432. As inprevious embodiments, the first needle 428 defines a needle pivot axis434, and a first actuator rod 435 is coupled to the first needle 428 torotate the needle 428 about the pivot axis 434. In this embodiment, whenthe first actuator rod 435 is moved in a direction 436 away from thefirst needle 428, the first needle 428 rotates in a first direction 438.As the first needle 428 moves in the first direction 438, the ferruleengaging tip on the curved arm 432 moves on an arcuate path towardscorresponding ferrule 440.

Second needle 442 has a flywheel portion (not easily visible in thisview), similar to flywheel portions described previously. The secondneedle 442 has a single curved arm 444. As in previous embodiments, thesecond needle 442 defines a needle pivot axis 434, and a second actuatorrod 446 is coupled to the second needle 442 to rotate the needle 442about the pivot axis 434. In this embodiment, when the second actuatorrod 446 is moved in a direction 448 away from the second needle 442, thesecond needle 442 rotates in the first direction 438. As the secondneedle 442 moves in the first direction 438, the ferrule engaging tip onthe curved arm 444 moves on an arcuate path towards correspondingferrule 450. The first pair of ferrules 440, 450 are each coupled todifferent ends of a first suture 452.

Third needle 454 has a flywheel portion (not easily visible in thisview), similar to flywheel portions described previously. The thirdneedle 454 also has a pair of curved arms 456A, 456B. As in previousembodiments, the third needle 454 defines a needle pivot axis 434. Athird actuator rod 458 is coupled to the third needle 454 to rotate thethird needle 454 about pivot axis 434. In this embodiment, when thethird actuator rod 458 is moved in a direction 460 toward the thirdneedle 454, the third needle 454 rotates in a second direction 462. Asthe third needle 454 moves in the second direction 462, the ferruleengaging tips on each of the curved arms 456A, 456B move on an arcuatepath towards corresponding ferrules 464A, 464B. This second pair offerrules 464A, 464B are each coupled to different ends of a secondsuture 466.

If each pair of curved arms 332, 444 and 456A, 456B are passed throughtissue (in this embodiment, in opposite directions), engaged with theircorresponding ferrules, and then rotated back to pull the first andsecond sutures 452, 466 through the tissue in a fashion as has beendisclosed in detail above, the resultant suture placement in tissue 468is illustrated schematically in FIGS. 27A (top view) and 27B (left sideview). Each end of the first suture 452 enters and exits the tissue 468at a distance farther from a potential incision point 470 than where theends of the second suture 466 enter and exit the same tissue 468. Theends of the placed sutures 452, 466 also face in opposite directions inthis embodiment. Unlike the previous embodiment, however, since the arcof the first pair of curved arms 432, 444 and the arc of the second pairof curved arms 456A, 456B are substantially the same, the first andsecond sutures 452, 466 each travel the same depth into the tissue 468.The suture stitches illustrated in FIGS. 27A and 27B are useful forsetting up a purse string suture closure prior to forming an incisiontherebetween so that the incision may be closed and/or drawn together asneeded during a surgical procedure.

FIGS. 28A and 28B illustrate another embodiment of a surgical suturingdevice 472 having a needle 474 rotatable within a head 476. As withprevious embodiments, the head 476 is coupled to a shaft 478, and anactuator 480 is coupled to the needle 474 by an actuator end effector482. The needle 474 defines a pivot axis 484, and the needle 474 alsohas a flywheel portion 486, similar to flywheel portions discussedpreviously. In this embodiment, however, the one or more curved arms 488of the needle 474 have an arc centerpoint 490A which does not coincidewith the needle pivot axis 484. Each of the one or more curved arms 488has a ferrule engaging tip 492 which is sized to engage and pick up acorresponding ferrule 494 held by the ferrule holder 496 in the devicehead 476. As before, the ferrule 494 may be coupled to a suture 498. Thedevice head 476, in conjunction with the flywheel portion of the needle474, define a bite area 500 as shown in FIG. 28A.

As illustrated in FIG. 28B, in this embodiment, when the actuator rod502 is moved 502 towards the head 476, the needle 474 rotates in a firstdirection 504 about the needle axis 484. The ferrule engaging tip 492can pick up the ferrule 494 as in previous embodiments, but in thisembodiment, it should be noted that the arc centerpoint 490B is in a newlocation when the curved arm is engaged because the arc centerpoint(490A in FIG. 28A, and 490B in FIG. 28B) does not coincide with theneedle axis 484. While this embodiment may not be preferred for someapplications since the curved arm 488 will tend to pull at tissue in thebite area 500, it is another possible embodiment.

FIGS. 29A-29N illustrate another method of suturing an annuloplasty ringto underlying tissue using the surgical suturing device of FIG. 14 .FIG. 29A schematically illustrates a surgical situation. Minimallyinvasive access has been gained to a chamber of the heart. Annulartissue 326 surrounding a mitral valve 40 has become enlarged and, as aresult, the valve's leaflets are no longer able to maintain propermitral valve closure. An annuloplasty ring, of a desired annulus size,may be installed over the annular tissue such that the annular tissue issnugged inward towards the prosthetic to reestablish a preferred,smaller mitral annulus. The annuloplasty ring 328 is initiallypositioned away from the annular tissue, for example, outside of thepatient's body. The suturing device 236 is ready to be used. Forconvenience, the handle, actuator, and entire shaft are not shown inthese views. As before, the device 236 has a bite area 295 defined atleast in part by the head 254 at the end of the shaft 242. The ferrule296, coupled to the end of suture 302 is held in the ferrule holder onone side of the bite area 295 in the device head 254. The curved arm 290and its ferrule engaging tip 292 are in a retracted position on theother side of the bite area 295.

As shown in FIG. 29B, the tissue bite area 295 is placed against theannuloplasty ring 328 from the side, such that the curved arm 290, if itwere to be engaged, would only pass once through the annuloplasty ring328 on its way to the ferrule 296. As illustrated in FIG. 29C, theneedle is actuated so the curved arm 290 and its ferrule engaging tip292 pass up through the annuloplasty ring 328 and into contact withferrule 296. As shown in FIG. 29D, the needle is de-actuated so that thecurved arm 290 and its ferrule engaging tip 292 (along with the attachedferrule) are pulled back down through the annuloplasty ring 328 and intoa retracted position again. As illustrated in FIG. 29E, the suturingdevice 236 may be pulled away 506 from the annuloplasty ring 328,thereby drawing more of the suture 302 down from the stitch in theannuloplasty ring 328. The ferrule 296 may be returned to the ferruleholder (not visible in this view) using the ferrule removal feature 259,as described above with regard to FIGS. 18D-18F, and the device 236 willbe ready to place a second stitch.

As shown in FIG. 29F, the tissue bite area 295 is placed onto theannular tissue 326 at a position which is intended to correspond to thefirst stitch that was already placed in the annuloplasty ring. As shownin FIG. 29G, the needle is actuated so that the curved arm 290 and itsferrule engaging tip 292 pass down through annular tissue 326 and backup into contact with the ferrule 296. As shown in FIG. 29H, the needleis de-actuated so that the curved arm 290 and its ferrule engaging tip292 (along with the attached ferrules 296) are pulled back through theannular tissue 236 and into a retracted position again. Since the end ofsuture 302 is coupled to the ferrule 296, part of the suture 302 is alsopulled through the annular tissue 236. As illustrated in FIG. 29I, thesuturing device 236 may be pulled away 508 from the annular tissue 326,thereby drawing more of the suture 302 up from the stitch in the annulartissue 326. The ferrule 296 may be returned to the ferrule holder (notvisible in this view) using the ferrule removal feature 259 as describedabove with regard to FIGS. 18D-18F, and the device 236 will be ready toplace a third stitch.

As shown in FIG. 29J, the tissue bite area 295 is once again placedagainst the annuloplasty ring 328 from the side, such that the curvedarm 290, if it were to be engaged, would only pass once through theannuloplasty ring 328 on its way to the ferrule 296. As illustrated inFIG. 29K, the needle is actuated so the curved arm 290 and its ferruleengaging tip 292 pass down through the annuloplasty ring 328 and intocontact with ferrule 296. As shown in FIG. 29L, the needle isde-actuated so that the curved arm 290 and its ferrule engaging tip 292(along with the attached ferrule) are pulled back up through theannuloplasty ring 328 and into a retracted position again. Asillustrated in FIG. 29M, the suturing device 236 may be pulled away 510from the annuloplasty ring 328, thereby drawing more of the suture 302up from this second stitch in the annuloplasty ring 328. The ferrule 296may be removed from the suture 302, leaving first and second ends 512,514 of the suture 302 protruding up from the annuloplasty ring 328. Ifdesired, the above method may be repeated at one or more additionallocations with one or more additional sutures. For simplicity, however,just a single suture 302 with its two suture ends 512, 514 are discussedin this example. As illustrated in FIG. 29N, the loose suture ends 512,514 may be secured with a mechanical fastener 516 to help hold theannuloplasty ring 328 in place. The suture ends 512, 514 are showntrimmed in FIG. 29N.

Some of the embodiments discussed above, such as the surgical suturingdevice of FIGS. 14-15 , have a ferrule release feature 259 which ispositioned to enable a ferrule to be returned to a ferrule holder afterit had previously been captured by a ferrule engaging tip of a needle.This resetting (or re-arming) of the ferrule enables a running stitch tobe performed with a single suture using the surgical suturing device.However, for other embodiments of surgical suturing devices, which donot have an integral ferrule release feature for re-arming the device,it may be desirable to have an apparatus and method for being able tore-arm the surgical suturing device. FIG. 30 is a perspective view ofone embodiment of a re-arming tool 518 for a surgical suturing device.The re-arming tool 518 has a needle ramp 520 and a positioning frame 522coupled to the needle ramp 520. As will be demonstrated in an examplebelow, in this embodiment, the positioning frame 522 is configured toengage a tissue bite area of a surgical suturing device. In otherembodiments, the positioning frame may be configured to engage any partof the surgical suturing device for the purpose of positioning theneedle ramp 520 relative to a travel path of one or more ferruleengaging tips of one or more needles.

The needle ramp 520 has a leading edge 524, a needle facing surface 526,and a trailing edge 528. In this embodiment, the leading edge 524 isrounded, but in other embodiments, the leading edge could have a sharperor differently shaped edge. In this embodiment, the needle ramp 520 hasan arcuate surface which is shaped to correspond with the arcuate pathof one or more curved arms of a needle, as will be discussed in moredetail below. The needle facing surface 526 is on a convex side of thearcuate needle ramp 520 in this embodiment.

The trailing edge 528 is biased away from the needle facing surface 520in this embodiment by a spring element 530 which couples the positioningframe 522 to the needle ramp 520. Suitable examples of a spring elementcould include, but are not limited to, a compression spring, a tensionspring, a torsion spring, a constant force spring, a variable forcespring, a leaf spring, a helical spring, and a machined spring. Althoughthe trailing edge 528 is integral with the needle ramp 520 in thisembodiment, in other embodiments, the trailing edge could be separatelymovable relative to the needle ramp 520. (For example, if the needleramp was coupled to the positioning frame without a spring element,while a separate trailing edge was biased by a spring element that wasalso coupled to the positioning frame).

FIGS. 31A-31C are partial cross-sectional side views of a surgicalsuturing device being re-armed with the re-arming tool of FIG. 30 . Thesuturing device in FIGS. 31A-31C is the same as the suturing device 48from FIG. 2 , discussed previously. The situation illustrated in FIG.31A is similar to the situation of FIG. 6C, also discussed previously.In FIG. 31A, the actuator rod 58 has been moved in a proximal direction532, which caused the needle 74 to rotate in an arcuate direction 534about its needle pivot axis. Although the needle 74 has more than onecurved arm and corresponding ferrule engaging tip in this embodiment,the side view only allows us to see what is happening with a singlecurved arm 88, its ferrule engaging tip 90, and its correspondingferrule 106 attached to the suture 114. It should be understood,however, that the described re-arming process can be occurring similarlyfor multiple curved arms at the same time. The ferrule engaging tip 90of the curved arm 88 (and the ferrule 106 which is coupled to them) arein a retracted position, which might occur, for example, after havingalready used the device 48 to create a first stitch in tissue or someother object.

As can also be seen in FIG. 31A, the re-arming tool 518 of FIG. 30 hasbeen positioned within the bite area 115 of the device 48. In thisembodiment, the positioning frame 522 engages the outside of the devicehead 66 and also passes through the tissue bite area 115. Since the viewof FIG. 31A is a partially exposed view, the back leg of the positioningframe 522 is visible as a broken line hidden object; the nearest leg isnot visible in this view.

As illustrated in FIG. 31B, the re-arming tool 518 is positioned so thatthe ferrule 106, while held by the ferrule engaging tip 90 of the curvedarm 88, will ride in proximity to and/or across the needle ramp 520 whenthe actuator rod 58 is moved in a distal direction 536, thereby causingthe needle 74 to rotate in another arcuate direction 538 about itsneedle pivot axis. While rotating in arcuate direction 538, the ferruleengaging tip 90 of the curved arm 88 passes from its retracted position(shown in FIG. 31A), past the needle ramp 520, over the trailing edge528, and returns the ferrule 106 to the ferrule holder 102. At thispoint, however, the ferrule 106 is still coupled to the ferrule engagingtip 90 of the curved arm 88.

Since the trailing edge 528 is biased away from the needle facingsurface (towards the curved arm 88 of the needle 74 in this embodiment),the trailing edge 528 of the re-arming tool 518 contacts the curved arm88 just before it meets the ferrule 106 at the ferrule engaging tip 90.In this position, illustrated in FIG. 31B, the trailing edge 528 willprevent the ferrule 106 from returning with the ferrule engaging tip 90if the needle 74 is rotated back to its retracted position. In FIG. 31C,the needle 74 has been rotated back to its retracted position withanother proximal movement 532 of the actuator rod 58. The trailing edge528 of the re-arming tool 518 has kept the ferrule 106 in the ferruleholder 102, while the ferrule engaging tip 90 of the curved arm 88 iscorrespondingly ferrule-free. At this stage, the re-arming tool 518 maybe removed and the device is ready to place another stitch in a desiredtissue or object location. Re-arming tool 518 and its equivalents areuseful for enabling multiple stitches to be placed with the same suturewithout having to handle the ferrule coupled to the suture in-betweenthe multiple stitches.

FIGS. 32A-32J illustrate another method of replacing a chordae tendinaeof the heart using the surgical suturing device of FIG. 2 . FIG. 32Aillustrates a surgical situation. Minimally invasive access has beengained to the left ventricle of the heart. A pathologic chord has beenremoved from the illustrated papillary muscle 40B, and the suturingdevice 48 is ready to be used. For convenience, the handle, actuator,and entire shaft are not shown in these views. As before, the device 48has a tissue bite area 124 defined at least in part by the head 66 atthe end of the shaft 54. First and second ferrules 106, 108, coupled tothe ends of suture 114 are held in ferrule holders (not visible in thisview) on the proximal side of the tissue bite area 124 in the devicehead 66. The first and second curved arms 88, 92 and their respectivefirst and second ferrule engaging tips 90, 94 are in a retractedposition on the distal side of the tissue bite area 124.

As shown in FIG. 32B, the tissue bite area 124 is placed over a leaflet540 of the mitral valve 40. As shown in FIG. 32C, the needle is actuatedso that the first and second curved arms 88, 92, and their respectiveferrule engaging tips, pass through the leaflet 540 in the tissue bitearea and engage the corresponding first and second ferrules 106, 108. Asshown in FIG. 32D, the needle is actuated so that the first and secondcurved arms 88, 92 and their respective ferrule engaging tips (as wellas the respective ferrules 106, 108 held by those ferrule engaging tips)are pulled back through the leaflet 540 in the tissue bite area and intoa retracted position again. Since the ends of suture 114 are coupled tothe ferrules 106, 108, the suture 114 is also pulled through the leaflet540. As illustrated in FIG. 32E, the suturing device 48 may be pulledaway 542 from the leaflet 540 in order to take up the slack in thesuture 114.

Next, as illustrated in FIG. 32F, the tissue bite area 124 is placedover the papillary muscle 40B. As shown in FIG. 32G, the needle isactuated so that the first and second curved arms 88, 92, and theirrespective ferrule engaging tips, pass through the papillary muscle 40Bin the tissue bite area and engage the corresponding first and secondferrules 106, 108. As shown in FIG. 32H, the needle is actuated so thatthe first and second curved arms 88, 92 and their respective ferruleengaging tips (as well as the respective ferrules 106, 108 held by thoseferrule engaging tips) are pulled back through the tissue 40B in thetissue bite area and into a retracted position again. Since the ends ofsuture 114 are coupled to the ferrules 106, 108, the suture 114 is alsopulled through the papillary muscle 40B. As illustrated in FIG. 32I, thesuturing device 48 may be pulled away 544 from the papillary muscle 40Bin order to take up the slack in the suture 114. The ferrules 106, 108may be removed from the suture 114, and the suture ends 546 may besecured with a mechanical fastener 548 once the desired replacementchord length 550 has been selected by adjusting the suture 114.

Various advantages of a suturing device for minimally invasive surgeryand needles and methods thereof have been discussed above. Embodimentsdiscussed herein have been described by way of example in thisspecification. It will be apparent to those skilled in the art that theforgoing detailed disclosure is intended to be presented by way ofexample only, and is not limiting. Various alterations, improvements,and modifications will occur and are intended to those skilled in theart, though not expressly stated herein. These alterations,improvements, and modifications are intended to be suggested hereby, andare within the spirit and the scope of the claimed invention.Additionally, the recited order of processing elements or sequences, orthe use of numbers, letters, or other designations therefore, is notintended to limit the claims to any order, except as may be specified inthe claims. Accordingly, the invention is limited only by the followingclaims and equivalents thereto.

What is claimed is:
 1. A suturing device for minimally invasive surgery,comprising: a housing; an actuator pivotably coupled to a first portionof the housing such that the actuator is pivotably displaceable betweena first actuator position and a second actuator position; a shaftextending from a proximal end to a distal end along a shaft axis,wherein the shaft defines an interior portion that extends from theproximal end of the shaft to the distal end of the shaft, and whereinthe proximal end of the shaft is coupled to a second portion of thehousing; a head portion coupled to the distal end of the shaft, the headportion defining a first holder configured to hold a first ferrulesecured to a first portion of suture; an actuator rod coupled to aportion of the actuator, wherein at least a portion of the actuator rodextends through the interior portion of the shaft, wherein as theactuator is pivoted from the first actuator position to the secondactuator position, a distal end of the actuator rod is displaced from afirst rod position to a second rod position, and wherein as the actuatoris pivoted from the second actuator position to the first actuatorposition, the distal end of the actuator rod is displaced from thesecond rod position to the first rod position; and a needle coupled tothe distal end of the actuator rod, the needle comprising a flywheelportion, a first arm coupled to a first portion of the flywheel portion,and a second arm coupled to a second portion of the flywheel portion,the first arm extending from a first end to a second end along a firstarm axis such that the first end of the first arm is coupled to thefirst portion of the flywheel portion, the second end of the first armhaving a first ferrule-engaging tip, the second arm extending from afirst end to a second end along a second arm axis such that the firstend of the second arm is coupled to the second portion of the flywheelportion, the second end of the second arm having a secondferrule-engaging tip, the needle being pivotable about a pivot axis thatextends through a third portion of the flywheel portion such that whenthe actuator rod displaces from the first rod position to the second rodposition, the needle rotates from a retracted position to an engagedposition, and wherein the distal end of the actuator rod is coupled to afourth portion of the flywheel portion such that the distal end of theactuator rod is coupled to the fourth portion in the retracted positionand in the engaged position, and wherein the first arm axis and thesecond arm axis are aligned when viewed along the pivot axis, wherein inthe retracted position, the first ferrule-engaging tip is disposedremote from the first holder, and in the engaged position, the firstferrule-engaging tip is disposed adjacent to or in contact with thefirst holder such that the first ferrule-engaging tip is configured tooperatively engage the first ferrule configured to be held in the firstholder.
 2. The suturing device of claim 1, wherein as the actuator ispivoted from the first actuator position to the second actuatorposition, the distal end of the actuator rod is displaced distally fromthe first rod position to the second rod position, and wherein as theactuator is pivoted from the second actuator position to the firstactuator position, the distal end of the actuator rod is displacedproximally from the second rod position to the first rod position. 3.The suturing device of claim 1, wherein the actuator rod is elongated,and a proximal end of the actuator rod is coupled to the portion of theactuator.
 4. The suturing device of claim 1, wherein the needle pivotsabout a pivot pin that is coupled to the head portion, wherein the pivotpin is coaxially aligned with the pivot axis of the needle.
 5. Thesuturing device of claim 1, wherein the first end of the first arm andthe first end of the second arm are integrally formed with the flywheelportion such that the flywheel portion, the first arm, and the secondarm form a single, unitary part.
 6. The suturing device of claim 1,wherein the first arm axis has an arcuate shape when viewed along thepivot axis.
 7. The suturing device of claim 1, wherein the fourthportion of the flywheel portion is disposed adjacent to a peripheraledge of the flywheel portion.
 8. The suturing device of claim 1, whereina portion of the actuator rod extends through a passage of the headportion, the passage extending from a proximal end to a distal end,wherein when the distal end of the actuator rod is in the first rodposition, the fourth portion of the flywheel portion is adjacent to theproximal end of the passage of the head portion.
 9. The suturing deviceof claim 1, wherein when the distal end of the actuator rod is in thesecond rod position, the fourth portion of the flywheel portion isadjacent to the distal end of the head portion.
 10. The suturing deviceof claim 1, wherein a portion of the housing defines a grip portion, andwherein in the first actuator position, a lever portion of the actuatoris in a first position relative to the grip portion of the housing andin the second actuator position, the lever portion of the actuator is ina second position relative to the grip portion of the housing.
 11. Thesuturing device of claim 1, wherein the head portion extends along theshaft axis from a proximal end to a distal end, and the proximal end ofthe head portion is coupled to the distal end of the shaft, and whereina notch is disposed along a portion of the head portion between theproximal end of the head portion and the distal end of the head portion,the notch defining a tissue bite area that is configured to receive aportion of tissue through which the first ferrule-engaging tip will passas the needle rotates from the retracted position to the engagedposition.
 12. The suturing device of claim 11, wherein the notch isformed along a lateral edge of the head portion and the notch extendsparallel to the shaft axis from a distal end of the notch to a proximalend of the notch.
 13. The suturing device of claim 12, wherein when theneedle is in the retracted position, the first ferrule-engaging tip isdisposed adjacent to the distal end of the notch, and when the needle isin the engaged position, the first ferrule-engaging tip is disposedadjacent to the proximal end of the notch.
 14. The suturing device ofclaim 1, wherein the distal end of the actuator rod is displacedlinearly from the first rod position to the second rod position.
 15. Thesuturing device of claim 1, wherein the distal end of the actuator rodis disposed within a recess formed at the fourth portion of the flywheelportion.
 16. The suturing device of claim 15, wherein the distal end ofthe actuator rod is rotatably disposed within the recess formed at thefourth portion of the flywheel portion.
 17. The suturing device of claim1, wherein displacing the distal end of the actuator rod from the firstrod position to the second rod position comprises displacing the distalend of the actuator rod distally from the first rod position to thesecond rod position.
 18. The suturing device of claim 1, wherein thehead portion defines a second holder configured to hold a second ferrulesecured to a second portion of suture, and when the needle is in theretracted position, the second ferrule-engaging tip is disposed remotefrom the second holder, and in the engaged position, the secondferrule-engaging tip is disposed adjacent to or in contact with thesecond holder such that the second ferrule-engaging tip is configured tooperatively engage the second ferrule configured to be held in thesecond holder.
 19. A method of manufacturing a suturing device, themethod comprising: pivotably coupling an actuator to a first portion ofa housing such that the actuator is pivotably displaceable between afirst actuator position and a second actuator position; coupling aproximal end of a shaft to a second portion of the housing, wherein theshaft defines an interior portion that extends from the proximal end ofthe shaft to a distal end of the shaft; coupling a head portion to thedistal end of the shaft, the head portion defining a first holderconfigured to hold a first ferrule secured to a first portion of suture;coupling an actuator rod to a portion of the actuator such that at leasta portion of the actuator rod extends through the interior portion ofthe shaft, wherein as the actuator is pivoted from the first actuatorposition to the second actuator position, a distal end of the actuatorrod is displaced from a first rod position to a second rod position, andwherein as the actuator is pivoted from the second actuator position tothe first actuator position, the distal end of the actuator rod isdisplaced from the second rod position to the first rod position;coupling a needle to the distal end of the actuator rod, the needlecomprising a flywheel portion, a first arm coupled to a first portion ofthe flywheel portion, and a second arm coupled to a second portion ofthe flywheel portion, the first arm extending from a first end to asecond end along a first arm axis such that the first end of the firstarm is coupled to the first portion of the flywheel portion, the secondend of the first arm having a first ferrule-engaging tip, the second armextending from a first end to a second end along a second arm axis suchthat the first end of the second arm is coupled to the second portion ofthe flywheel portion, the second end of the second arm having a secondferrule-engaging tip, the needle being pivotable about a pivot axis thatextends through a third portion of the flywheel portion such that whenthe actuator rod displaces from the first rod position to the second rodposition, the needle rotates from a retracted position to an engagedposition, and wherein the distal end of the actuator rod is coupled to afourth portion of the flywheel portion such that the distal end of theactuator rod is coupled to the fourth portion in the retracted positionand in the engaged position, and wherein the first arm axis and thesecond arm axis are aligned when viewed along the pivot axis, wherein inthe retracted position, the first ferrule-engaging tip is disposedremote from the first holder, and in the engaged position, the firstferrule-engaging tip is disposed adjacent to or in contact with thefirst holder such that the first ferrule-engaging tip is configured tooperatively engage the first ferrule configured to be held in the firstholder.
 20. The method of claim 19, further comprising coupling aproximal end of the actuator rod to the portion of the actuator.
 21. Themethod of claim 19, wherein the first end of the first arm and the firstend of the second arm are integrally formed with the flywheel portionsuch that the flywheel portion, the first arm, and the second arm form asingle, unitary part.
 22. The method of claim 19, wherein the first armaxis has an arcuate shape when viewed along the pivot axis.
 23. Themethod of claim 19, wherein the fourth portion of the flywheel portionis disposed adjacent to a peripheral edge of the flywheel portion. 24.The method of claim 23, further comprising extending a portion of theactuator rod through a passage of the head portion, the passageextending from a proximal end to a distal end, wherein when the distalend of the actuator rod is in the first rod position, the second portionof the flywheel portion is adjacent to the proximal end of the passageof the head portion.